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Recruiting NCT05775718

Shingrix In Recipients of Allogeneic Transplants

Phase II Interventional Bone Marrow Transplant Stem Cell Transplant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zoster Vaccine Recombinant.
Who it may be relevant to
Registry conditions: Bone Marrow Transplant, Stem Cell Transplant. Basic parameters: 18 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Safety and Immunogenicity of Shingrix Administered to Recipients of Allogeneic Peripheral and Cord Blood Stem Cell Transplants: Effect of Timing of Vaccination After Transplantation

Overview

This research is designed to determine if the adjuvanted recombinant glycoprotein E (gE) herpes zoster (HZ) vaccine (Shingrix) has acceptable immunogenicity and safety in people who have undergone allogeneic stem cell transplant (allo-SCT). Specifically, it will determine the effect of the interval after transplantation on the immune response and if an additional dose of vaccine is needed to improve the vaccine-induced responses.

Detailed description

This is a phase II, single center, prospective, unblinded, immunogenicity and safety study. It is anticipated that enrollment will take approximately 6 months. Duration of participation for study subjects is approximately 1 year. During this interval, participants will continue to receive clinical care from the BMT center, which will ensure retention.

Participants will be recruited at their routine clinic visits, which take place every 6 months post-transplantation, or will be recruited by phone. Participants will be consented by study personnel in coordination with the BMT health care providers and subsequently followed in Dr. Levin's Vaccine Research Clinic, where they will also receive the 3rd dose of vaccine.

Interventions

  • Drug Zoster Vaccine Recombinant
    Injection

Primary outcome measures

  • Compare the immune response via blood draw of Cohort 1 prior to enrollment to ≥1 year post-transplant [Time frame: 1 Year]
  • Compare the immune response via blood draw of Cohort 1 prior to enrollment to ≥1 year post-transplant to immune-competent older recipients [Time frame: 1 Year]
  • Determine adverse events after a 3rd dose of Shingrix administered 18-30 months after primary immunization for Cohort 1 [Time frame: 1 Year]
  • Compare gE-specific CMI via blood draw in Cohort 1 recipients at 30-60 days after the 3rd dose of Shingrix with responses before the administration of the 3rd dose [Time frame: 1 Year]
  • Compare gE-specific CMI via blood draw in Cohort 1 recipients at 365 days after the 3rd dose of Shingrix with responses before the administration of the 3rd dose [Time frame: 1 Year]
  • Compare the immune response via blood draw of Cohort 2 prior to enrollment to ≥1 year post-transplant [Time frame: 1 Year]
  • Compare the immune response via blood draw of Cohort 2 prior to enrollment to ≥1 year post-transplant to immune-competent older recipients [Time frame: 1 Year]
  • Determine adverse events after a 3rd dose of Shingrix administered 18-30 months after primary immunization for Cohort 2 [Time frame: 1 Year]
  • Compare gE-specific CMI via blood draw in Cohort 2 recipients at 30-60 days after the 3rd dose of Shingrix with responses before the administration of the 3rd dose [Time frame: 1 Year]
  • Compare gE-specific CMI via blood draw in Cohort 2 recipients at 365 days after the 3rd dose of Shingrix with responses before the administration of the 3rd dose [Time frame: 1 Year]
Secondary outcome measures (12)
  • Compare gE-specific antibody responses via blood draw in allo-SCT recipients 18-30 months after primary immunization with Shingrix with responses of older immune-competent adults at 1-2 months after the administration of the primary 2-dose regimen [Time frame: 1 Year]
  • Compare gE-specific antibody responses via blood draw in allo-SCT recipients 18-30 months after primary immunization with Shingrix with responses of immune-competent adults at 1 year after the administration of the primary 2-dose regimen [Time frame: 1 Year]
  • Compare VZV-specific IL2 responses via blood draw in allo-SCT recipients 18-30 months after primary immunization with Shingrix with responses of older immune-competent adults at 1-2 months after administration of the primary 2-dose regimen [Time frame: 1 Year]
  • Compare VZV-specific IL2 responses via blood draw in allo-SCT primary immunization 1-2 months after 3rd dose of Shingrix with responses of older immune-competent adults at 1-2 months after administration of primary 2-dose response. [Time frame: 1 Year]
  • Compare VZV-specific IL2 responses via blood draw in allo-SCT recipients 1 year after the 3rd dose of Shingrix with responses of older immune-competent adults at 1 year after administration of the primary 2-dose regimen. [Time frame: 1 Year]
  • Compare the gE-specific T cell differentiation via blood draw in allo-SCT recipients before the 3rd dose of Shingrix to imune-competent adults [Time frame: 1 Year]
  • Compare the gE-specific T cell differentiation via blood draw in allo-SCT recipients after the 3rd dose of Shingrix to immune-competent adults [Time frame: 1 Year]
  • Compare the gE-specific trained immunity profiles via blood draw in allo-SCT recipients before the 3rd dose of Shingrix with the profile of immune-competent adults [Time frame: 1 year]
  • Compare the gE-specific trained immunity profiles via blood draw in allo-SCT recipients after the 3rd dose of Shingrix with the profiles of immune-competent adults [Time frame: 1 year]
  • Determine the incidence of HZ in allo-SCT recipients who received 3 doses of Shingrix. [Time frame: 1 year]
  • Determine the severity of HZ via blood draw and patient dairy in allo-SCT recipients who received 3 doses of Shingrix. [Time frame: 1 year]
  • Determine the predictive value of TTV titer via blood draw on the immunogenicity of the 3rd dose of Shingrix in allo-SCT [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Allo-SCT recipients being age 18 - 79 years at time of allo-SCT.
  • Written informed consent being obtained from the subject
  • Two doses of RZV, separated by 2 to 6 months, administered at least 1 year after allo-SCT.
  • Enrollment at >/= 18 months after second dose of Shingrix.
  • Female subjects of childbearing potential (FOCBP) enrolled in the study only if they:
  • have practiced adequate contraception for 30 days prior to vaccination with any dose of zoster vaccine and
  • have a negative pregnancy test on the day of each dose of zoster vaccine and
  • agree to continue adequate contraception during the vaccination period and for 2 months after receipt of the vaccine.
  • Investigator belief that the participant will comply with the requirements of the protocol

Exclusion criteria

  • Active Graft Versus Host Disease (aGVHD) at the time of enrollment and receipt of the third dose of RZV
  • Having received ≥20 mg prednisone for more than 2 weeks (or equivalent) in the 8 weeks preceding enrollment.
  • Receiving any significant immunosuppressive therapy other than for graft maintenance, in the opinion of the investigator.
  • Having received a live attenuated vaccine within the last 4 weeks, or inactivated vaccine in the last 2 weeks, prior to enrollment.
  • Having a history of HZ after the administration of the primary 2-dose RZV immunization regimen.
  • Pregnancy or breastfeeding
  • Receiving investigational drugs from 30 day before enrollment or planned during the study
  • Inability of participants unable to comply with the study schedule in the opinion of the investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Colorado Hospital — Aurora

Identifiers

NCT: NCT05775718 · 22-0394.cc · NCI-2023-04097

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗